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Last Updated: August 11, 2022

DOVATO Drug Patent Profile


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When do Dovato patents expire, and when can generic versions of Dovato launch?

Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-two patent family members in forty-seven countries.

The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.

DrugPatentWatch® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DOVATO
Drug Prices for DOVATO

See drug prices for DOVATO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DOVATO
Generic Entry Date for DOVATO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DOVATO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 1
Saint Michael's Medical CenterPhase 4
Societa' Italiana Di Malattie Infettive E TropicaliPhase 3

See all DOVATO clinical trials

Paragraph IV (Patent) Challenges for DOVATO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DOVATO Tablets dolutegravir sodium; lamivudine 50 mg/300 mg 211994 1 2019-07-30

US Patents and Regulatory Information for DOVATO

DOVATO is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOVATO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DOVATO

Antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DOVATO

NEW COMBINATION
Exclusivity Expiration: See Plans and Pricing

TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 51
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11209788
Estimated Expiration: See Plans and Pricing

Patent: 14202404
Estimated Expiration: See Plans and Pricing

Patent: 14202405
Estimated Expiration: See Plans and Pricing

Patent: 14202406
Estimated Expiration: See Plans and Pricing

Patent: 16204987
Estimated Expiration: See Plans and Pricing

Patent: 17268621
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012018670
Estimated Expiration: See Plans and Pricing

Canada

Patent: 87691
Estimated Expiration: See Plans and Pricing

Patent: 67453
Estimated Expiration: See Plans and Pricing

Patent: 03988
Estimated Expiration: See Plans and Pricing

Patent: 60290
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002080
Estimated Expiration: See Plans and Pricing

China

Patent: 2791129
Estimated Expiration: See Plans and Pricing

Patent: 5311033
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 02152
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120423
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150770
Estimated Expiration: See Plans and Pricing

Patent: 0180855
Estimated Expiration: See Plans and Pricing

Patent: 0181531
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16509
Estimated Expiration: See Plans and Pricing

Patent: 20457
Estimated Expiration: See Plans and Pricing

Patent: 21040
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 012000205
Estimated Expiration: See Plans and Pricing

Patent: 021000147
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012106
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5176
Estimated Expiration: See Plans and Pricing

Patent: 2868
Estimated Expiration: See Plans and Pricing

Patent: 7601
Estimated Expiration: See Plans and Pricing

Patent: 1290583
Estimated Expiration: See Plans and Pricing

Patent: 1690872
Estimated Expiration: See Plans and Pricing

Patent: 1892277
Estimated Expiration: See Plans and Pricing

Patent: 2190473
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Patent: 51249
Estimated Expiration: See Plans and Pricing

Patent: 94972
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 79522
Estimated Expiration: See Plans and Pricing

Patent: 09629
Estimated Expiration: See Plans and Pricing

Patent: 50335
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26849
Estimated Expiration: See Plans and Pricing

Patent: 37812
Estimated Expiration: See Plans and Pricing

Patent: 40554
Estimated Expiration: See Plans and Pricing

Patent: 800042
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1007
Estimated Expiration: See Plans and Pricing

Patent: 5182
Estimated Expiration: See Plans and Pricing

Patent: 7267
Estimated Expiration: See Plans and Pricing

Patent: 7658
Estimated Expiration: See Plans and Pricing

Patent: 1959
Estimated Expiration: See Plans and Pricing

Japan

Patent: 68386
Estimated Expiration: See Plans and Pricing

Patent: 13518107
Estimated Expiration: See Plans and Pricing

Patent: 16145204
Estimated Expiration: See Plans and Pricing

Patent: 17008087
Estimated Expiration: See Plans and Pricing

Patent: 18127473
Estimated Expiration: See Plans and Pricing

Patent: 19167371
Estimated Expiration: See Plans and Pricing

Patent: 21091705
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 932970
Estimated Expiration: See Plans and Pricing

Patent: 2018013
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0090
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8334
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6891
Estimated Expiration: See Plans and Pricing

Patent: 7937
Estimated Expiration: See Plans and Pricing

Patent: 7938
Estimated Expiration: See Plans and Pricing

Patent: 12008774
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 182
Estimated Expiration: See Plans and Pricing

Patent: 058
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 002
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1319
Estimated Expiration: See Plans and Pricing

Patent: 7824
Estimated Expiration: See Plans and Pricing

Patent: 7826
Estimated Expiration: See Plans and Pricing

Patent: 7827
Estimated Expiration: See Plans and Pricing

Norway

Patent: 18036
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Peru

Patent: 121524
Estimated Expiration: See Plans and Pricing

Patent: 160180
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016500195
Estimated Expiration: See Plans and Pricing

Patent: 018502489
Estimated Expiration: See Plans and Pricing

Poland

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500177
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 123
Estimated Expiration: See Plans and Pricing

Patent: 323
Estimated Expiration: See Plans and Pricing

Patent: 728
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2614
Estimated Expiration: See Plans and Pricing

Patent: 201509476R
Estimated Expiration: See Plans and Pricing

Patent: 201707183T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1205586
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1830715
Estimated Expiration: See Plans and Pricing

Patent: 1883750
Estimated Expiration: See Plans and Pricing

Patent: 1964923
Estimated Expiration: See Plans and Pricing

Patent: 120128640
Estimated Expiration: See Plans and Pricing

Patent: 160111536
Estimated Expiration: See Plans and Pricing

Patent: 170078868
Estimated Expiration: See Plans and Pricing

Patent: 180078358
Estimated Expiration: See Plans and Pricing

Spain

Patent: 43066
Estimated Expiration: See Plans and Pricing

Patent: 70811
Estimated Expiration: See Plans and Pricing

Patent: 88925
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000376
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1807704
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5556
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DOVATO around the world.

Country Patent Number Title Estimated Expiration
Australia 2014202404 ANTIVIRAL THERAPY See Plans and Pricing
Slovenia 1874117 See Plans and Pricing
Hong Kong 1209629 抗病毒治療 (ANTIVIRAL THERAPY) See Plans and Pricing
European Patent Office 2932970 THÉRAPIE ANTIVIRALE (ANTIVIRAL THERAPY) See Plans and Pricing
Netherlands 300676 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DOVATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 C20140020 00130 Estonia See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
2932970 18C1043 France See Plans and Pricing PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
1874117 300676 Netherlands See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117 202 50006-2014 Slovakia See Plans and Pricing PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
2932970 LUC00090 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Harvard Business School
Express Scripts
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.